Safety and Efficacy Study of Neural Progenitor Cell Transplantation and Paracrine Factors From Human Mesenchymal Stem Cells to Treat Newborn With Hypoxic-ischemic Encephalopathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Neonatal Behavioral Neurological Assessment
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of allogenic neural progenitor cell and paracrine factors of human mesenchymal stem cells for patients with moderate/severe Hypoxic-Ischemic Encephalopathy
详细描述
Neonates diagnosed moderate/severe Hypoxic-Ischemic Encephalopathy after birth will receive routine therapy and be randomized to four arms for allogenic neural progenitor cells transplantation，paracrine factors of human mesenchymal stem cells intrathecal injection，combination of cell and factor or only routine therapy. Patients will be followed for neurodevelopmental outcome at 12 and 18 months in Pediatrics of Navy General Hospital. Magnetic Resonance Imaging, electroencephalogram, Bailey scores, Peabody development measure scale and Gross motor function measure assessment will be obtained in the following research.Results will be analyzed and described in study reports.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age ≥ 34weeks, body weight ≥ 2kg.
- •1 minute apgar score ≤3, and 5 minutes apgar score ≤5, OR umbilical arterial blood gas potential of hydrogen<7.0, OR 30 minutes base excess≤-12 mmol/L, OR need for ventilation 5 minutes after birth.
- •All infants must have signs of encephalopathy (such as convulsion, coma, dystonia, abnormal primitive reflex and irregular respiration) within 6 hours of age or continued abnormal EEG for more than 24h.
排除标准
- •Does not meet the inclusion criteria
- •Suffer from other serious organic disease or congenital, hereditary metabolic diseases
- •Intracranial active infection, or neuromuscular damage outside central nervous system
- •potential of hydrogen / electrolyte disorders without improvement or stability
- •Coagulation disorders associated with bleeding tendency
- •Immune function is not perfect
- •Patients or his guardian refuse consent.
- •Patients or his guardian don't accept the follow-up schedule.
结局指标
主要结局
Neonatal Behavioral Neurological Assessment
时间窗: 28days after birth
number of adverse events
时间窗: 7days after cell or factor injection
adverse events like fever、infection、seizures、hemorrhage coursed by interventions
次要结局
- Bayley score(18 months after birth)
- Peabody development measure scale(18 months after birth)
- Number of death(1 years after birth)
- Number of participants with treatment-related central nervous tumor as assessed by Magnetic Resonance Imaging or CT(5 years after birth)
研究者
Zuo Luan
Principal Investigator
Navy General Hospital, Beijing